Reported Aug 6, 2025 · Ongoing
RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
Siemens Healthcare Diagnostics Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Healthcare Diagnostics Inc · 2 Edgewater Dr · Norwood, MA · 02062-4637
Is this the product you have?
- RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack)
- Material Number10329097
- Lot codes and dates
- Material Number10329097
- GTIN Number00630414482163
- Lot NumberWW/08925
- Expiration Date12/03/2025
- Amount recalled
- 1,477 units
Where it was sold
- Nationwide
Why it was recalled
Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Waste Cartridge Lot WW/08925 due to a manufacturing error causing positive and negative bias in Ionized Calcium, Potassium, pH, Chloride, pCO2, Glucose and Lactate analytes and their derivatives. Four complaints were filed related to this event that led to Siemens Healthcare Diagnostics identifying an error in the manufacturing process and initiated corrective actions. Use of the affected device may result in errors during QC which could lead to a delay in patient treatment. If bias generated from this issue is not caught during QC erroneous results may cause temporary or medically reversible adverse health consequences to patients.
This product could cause temporary or reversible health problems — stop using it.
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